Table 2.
Commercially available transdermal patches approved by the US FDA
| Drug (Trade name, year of FDA approval) | Type | Indication | Patch design | Dose and size of patch – Delivery rate | Site of application | Duration of application |
|---|---|---|---|---|---|---|
| Buprenorphine (Butrans®, 2010) | Therapeutic | Chronic pain | DIA | 5 mg in 20.25 (6.25)a cm2 – 5 μg·h−1 7.5 mg in 33.65 (7.5) cm2 – 7.5 μg·h−1 10 mg in 30.60 (12.5) cm2 – 10 μg·h−1 15 mg in 42.48 (18.75) cm2 – 15 μg·h−1 20 mg in 51.84 (25) cm2 – 20 μg·h−1 |
Upper outer arm, upper chest, upper back or the side of the chest | 7 days |
| Clonidine (Catapres-TTS®, 1984) | Therapeutic | Hypertension | Reservoir/Membrane | 2.5 mg in 3.5 cm2 – 0.1 mg·day−1 5.0 mg in 7.0 cm2 – 0.2 mg·day−1 7.5 mg in 10.5 cm2 – 0.3 mg·day−1 |
Upper outer arm or upper chest | 7 days |
| Oestradiol (Estraderm®, 1986) | Therapeutic | Female HRT | Reservoir/Membrane | 4 mg in 18 (10) cm2 – 0.05 mg·day−1 8 mg in 31 (20) cm2 – 0.10 mg·day−1 |
Trunk of the body including the buttocks and abdomen | 3–4 days |
| Oestradiol (Climara®, 1994) | Therapeutic | Female HRT | DIA | 2 mg in 6.5 cm2 – 0.025 mg·day−1 2.85 mg in 9.375 cm2 – 0.0375 mg·day−1 3.8 mg in 12.5 cm2 – 0.05 mg·day−1 4.55 mg in 15 cm2 – 0.06 mg·day−1 5.7 mg in 18.75 cm2 – 0.075 mg·day−1 7.6 mg in 25 cm2 – 0.1 mg·day−1 |
Lower abdomen or upper quadrant of the buttock | 7 days |
| Oestradiol (Vivelle®, 1994) | Therapeutic | Female HRT | DIA | 4.33 mg in 14.5 cm2 – 0.05 mg·day−1 8.66 mg in 29.0 cm2 – 0.1 mg·day−1 |
Trunk of the body including abdomen and buttocks | 3–4 days |
| Oestradiol (Alora®, 1996) | Therapeutic | Female HRT | DIA | 0.77 mg in 9 cm2 – 0.025 mg·day−1 1.5 mg in 18 cm2 – 0.05 mg·day−1 2.3 mg in 27 cm2 – 0.075 mg·day−1 3.1 mg in 36 cm2 – 0.1 mg·day−1 |
Lower abdomen, upper quadrant of the buttock or outer aspect of the hip | 3–4 days |
| Oestradiol (Vivelle-Dot®, 1999) | Therapeutic | Female HRT | DIA | 0.39 mg in 2.5 cm2 – 0.025 mg·day−1 0.585 mg in 3.75 cm2 – 0.0375 mg·day−1 0.78 mg in 5.0 cm2 – 0.05 mg·day−1 1.17 mg in 7.5 cm2 – 0.075 mg·day−1 1.56 mg in 10.0 cm2 – 0.1 mg·day−1 |
Lower abdomen | 3–4 days |
| Oestradiol (Menostar®, 2004) | Therapeutic | Female HRT | DIA | 1 mg in 3.25 cm2 – 0.014 mg·day−1 | Lower abdomen | 7 days |
| Oestradiol (Minivelle®, 2012) | Therapeutic | Female HRT | DIA | 0.62 mg in 2.48 cm2 – 0.0375 mg·day−1 0.83 mg in 3.30 cm2 – 0.05 mg·day−1 1.24 mg in 4.95 cm2 – 0.075 mg·day−1 1.65 mg in 6.6 cm2 – 0.1 mg·day−1 |
Lower abdomen or buttocks | 3–4 days |
| Oestradiol (E)/Norethindrone (NT) (Combipatch®, 1998) | Therapeutic | Female HRT | DIA | 0.62 mg E/2.7 mg NT in 9 cm2 − 0.05/0.14 mg E/NT per day 0.51 mg E/4.8 mg NT in 16 cm2 − 0.05/0.25 mg E/NT per day |
Lower abdomen | 3–4 days |
| Ethinyl oestradiol (EE)/Norelgestromin (NL) (Ortho Evra®, 2001) | Therapeutic | Female contraception | DIA | 0.75 mg EE/6.00 mg NL in 20 cm2 − 0.035/0.15 mg EE/NL per day | Buttock, abdomen, upper outer arm or upper torso | 7 days |
| Oestradiol (E)/Levonorgestrel (L) (Climara Pro®, 2003) | Therapeutic | Female HRT | DIA | 4.40 mg E/1.39 mg L in 22 cm2 – 0.045/0.015 mg E/L per day | Lower abdomen | 7 days |
| Fentanyl (Duragesic®, 1990) | Therapeutic | Chronic pain | DIAb | 2.1 mg in 5.25 cm2 – 12.5 μg·h−1 4.2 mg in 10.5 cm2 – 25 μg·h−1 8.4 mg in 21 cm2 – 50 μg·h−1 12.6 mg in 31.5 cm2 – 75 μg·h−1 16.8 mg in 42 cm2 – 100 μg·h−1 |
Chest, back, flank or upper arm | 72 h |
| Granisetron (Sancuso®, 2008) | Therapeutic | Chemotherapy-induced nausea and vomiting | DIA | 34.3 mg in 52 cm2 – 3.1 mg per 24 h | Upper outer arm | Up to 7 days |
| Methylphenidate (Daytrana®, 2006) | Therapeutic | ADHD | DIA | 27.5 mg in 12.5 cm2 – 1.1 mg·h−1 41.3 mg in 18.75 cm2 – 1.6 mg·h−1 55 mg in 25 cm2 – 2.2 mg·h−1 82.5 mg in 37.5 cm2 – 3.3 mg·h−1 |
Hip area, avoiding the waistline | Up to 9 h in a day |
| Nitroglycerin (Nitro-Dur®, 1995) | Therapeutic | Angina pectoris | DIA | 20 mg in 5 cm2 – 0.1 mg·h−1 40 mg in 10 cm2 – 0.2 mg·h−1 60 mg in 15 cm2 – 0.3 mg·h−1 80 mg in 20 cm2 – 0.4 mg·h−1 120 mg in 30 cm2 – 0.6 mg·h−1 160 mg in 40 cm2 – 0.8 mg·h−1 |
Chest, shoulder, upper arm or back (hairless area) | 12–14 h |
| Nitroglycerin (Minitran®, 1996) | Therapeutic | Angina pectoris | DIA | 9 mg in 3.3 cm2 – 0.1 mg·h−1 18 mg in 6.7 cm2 – 0.2 mg·h−1 36 mg in 13.3 cm2 – 0.4 mg·h−1 54 mg in 20.0 cm2 – 0.6 mg·h−1 |
Chest, shoulder, upper arm or back (hairless area) | 12–14 h |
| Oxybutynin (Oxytrol®, 2003) | Therapeutic | Overactive bladder | DIA | 36 mg in 39 cm2 – 3.9 mg·day−1 | Abdomen, buttocks or hip | 3–4 days |
| Rivastigmine (Exelon®, 2007) | Therapeutic | Alzheimer's and Parkinson's disease | Matrix | 9 mg in 5 cm2 – 4.6 mg per 24 h 18 mg in 10 cm2 – 9.5 mg per 24 h 27 mg in 15 cm2 – 13.3 mg per 24 h |
Upper/lower back, upper arm or chest | 24 h |
| Rotigotinec (Neupro®, 2007) | Therapeutic | Parkinson's disease Restless legs syndrome |
DIA | 2.25 mg in 5 cm2 – 1 mg per 24 h (*) 4.5 mg in 10 cm2 – 2 mg per 24 h 6.75 mg in 15 cm2 – 3 mg per 24 h (*) 9 mg in 20 cm2 – 4 mg per 24 h 13.5 mg in 30 cm2 – 6 mg per 24 h 18 mg in 40 cm2 – 8 mg per 24 h (*) |
Abdomen, thigh, hip, flank, shoulder or upper arm | 24 h |
| Scopolamine (Transderm Scōp®,1981) | Therapeutic | Motion sickness | Reservoir/Membrane | 1.5 mg in 2.5 cm2 – 1.0 mg per 3 days | Behind one ear | 72 h |
| Selegiline (Emsam®, 2006) | Therapeutic | Major depressive disorder | DIA | 20 mg in 20 cm2 – 6 mg per 24 h 30 mg in 30 cm2 – 9 mg per 24 h 40 mg in 40 cm2 – 12 mg per 24 h |
Upper chest or back, upper thigh or the outer surface of the upper arm | 24 h |
| Testosteroned (Androderm®, 1995) | Therapeutic | Hypogonadism | Reservoir/Membrane | 9.7 mg in 32 cm2 (6) – 2 mg·day−1 (#) 12.2 mg in 37 cm2 (7.5) – 2.5 mg·day−1 19.5 mg in 39 cm2 – (12) 4 mg·day−1 (#) 24.3 mg in 44 cm2 – (15) 5 mg·day−1 |
Back, abdomen, thighs or upper arm | 24 h |
| Nicotine (Nicoderm CQ®, 1991)e | OTC | Smoking cessation | Reservoir/Membrane | 36 mg in 7 cm2 – 7 mg per 24 h 75 mg in 15 cm2 – 14 mg per 24 h 114 mg in 22 cm2 – 21 mg per 24 h |
Anywhere on the body, avoiding joints | 24 h |
| Nicotine (Nicorette®)f | OTC | Smoking cessation | Matrix | 8.3 mg in 10 cm2 – 5 mg per 16 h 16.6 mg in 20 cm2 – 10 mg per 16 h 24.9 mg in 30 cm2 – 15 mg per 16 h |
To an area on the upper body or upper outer arm that is non-hairy, intact, non-irritated, clean and dry | 16 h |
| Nicotine (Nicorette® Invisipatch®)f | OTC | Smoking cessation | Matrix | 15.75 mg in 9 cm2 – 10 mg per 16 h 23.62 mg in 13.5 cm2 – 15 mg per 16 h 39.7 mg in 22.5 cm2 – 25 mg per 16 h |
A clean, intact, dry and hairless skin of the thigh, arm or chest | 16 h |
| Nicotine (Habitrol®, 1990)g | OTC | Smoking cessation | Matrix | 17.5 mg in 10 cm2 – 7 mg per 24 h 35 mg in 20 cm2 – 14 mg per 24 h 52.5 mg in 30 cm2 – 21 mg per 24 h |
Upper body or the outer part of the arm | 24 h |
| Sumatriptan (Zecuity®, 2013) | Active | Migraine | Iontophoretic system | 36 mg in 7 cm2 – 6.5 mg per 4 h | Upper arm or tight | 4 h |
| Capsaicin (Qutenza®, 2009) | Topical | Neuropathic pain | DIA | 179 mg in 280 cm2 – No information on delivery rate | The most painful areas, excluding face and scalp | Single 60 min application of up to four patches |
| Diclofenac epolamine (Flector®, 2007) | Topical | Topical treatment acute pain | DIA | 180 mg in 140 cm2 No information on delivery rate |
The most painful area | 12 h |
| Lidocaine (Lidoderm®, 1999) | Topical | Post-herpetic neuralgia pain | DIA | 700 mg in 140 cm2 21 mg·12 h−1 |
The most painful area, avoiding the contact with the eyes | Up to three patches only once for up to 12 h within a 24 h period |
| Lidocaine (L)/Tetracaine (T) (Synera®, 2005) | Topical | Local dermal analgesia | Eutectic mixture – CHADD® technology | 70 mg L per 70 mg T in 50 cm2 – 1.7/1.6 mg L/T per 30 min | Site of venipuncture, i.v. cannulation or superficial dermatological procedure | 20–30 min |
| Menthol (M)/Methyl salicylate (MS) (Salonpas®, 2008) | Topical | Muscles and joints pain | DIA | 3% M/10% MS in 70 cm2 | The affected area | Up to 8–12 h |
| Oestradiol (Evamist®, 2007)h | Therapeutic | Menopausal symptoms | Cutaneous solution | 1.53 mg per spray (90 μL) | The inside of the forearm between the elbow and the wrist | One spray once daily (starting dose) |
| Testosterone (Axiron®, 2010)h | Therapeutic | Hypogonadism | Cutaneous solution | 30 mg per pump actuation | The axilla (armpit) | 2 pump actions once daily (starting dose) |
a(x) Size of patch reported corresponds to the active surface except for Butrans, Estraderm and Androderm patches where both active and overall surface are reported. bPrior to July 2009, a reservoir/membrane patch design was on the market. Following numerous reports of deaths and life-threatening side effects due to a serious design defect of the reservoir patch (risk of drug leakage from the patches), the company moved to a DIA patch design. cIn 2008, the product has been withdrawn from the US market due to the formation of rotigotine crystals in the patches and in 2012 Neupro was re-approved by the FDA with three new strengths (*). dIn 2011, the two patch strengths available on the market were discontinued and replaced by two new smaller size and lower-dose patches (#) but not as a result of any safety or efficacy concerns. eNicoderm CQ in the United States, NiQuitin® in the UK and Nicabate® in Australia. fNicorette is not FDA approved and available in the UK. gHabitrol in the United States and Canada, Nicotinell® in the UK. hEvamist and Axiron are cutaneous solutions using the Patchless Patch® delivery method developed by Acrux Ltd. Data source: FDA (2014) and products' PI.
ADHD, attention deficit hyperactivity disorder; CHADD, controlled heat-aided drug delivery; HRT, hormone replacement therapy.